Winding mandrel for vasoocclusive coils

ABSTRACT

The winding mandrel includes a pair of generally rounded-cube shaped or orthogonally flat-sided spherical main bodies connected together and having a plurality of cylindrical posts for forming vasoocclusive coils. The main bodies are connected together by a transition post, and the posts of the two main bodies are typically offset. A front end post and back end post are disposed on the front and rear ends of the mandrel. A short winding post member may be added between the connections of the two main bodies to provide additional winding posts.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is based upon Provisional Application No. 60/899,967,filed 7 Feb. 2007.

BACKGROUND OF THE INVENTION

This invention relates generally to vasoocclusive devices, and moreparticularly concerns a mandrel for forming at least a portion of avasoocclusive coil in a three dimensional configuration by winding ofthe coil about one or more portions of the mandrel.

Vasoocclusion devices are therapeutic devices that are placed within thevasculature of the human body, typically via a catheter, either to blockthe flow of blood through a vessel making up that portion of thevasculature through the formation of an embolus, or to form such anembolus within an aneurysm stemming from the vessel. The vasoocclusivedevices can take a variety of configurations, and are generally formedof one or more elements that are larger in the deployed configurationthan when they are within the delivery catheter prior to placement. Onewidely used vasoocclusive device is a helical wire coil having adeployed configuration which may be dimensioned to engage the walls ofthe vessels. For example, the vasoocclusive device may include one ormore vasoocclusive members wound to form a generally spherical or ovoidshape in a relaxed state. Vasoocclusive members can be wound around anappropriately shaped mandrel or form and then heat-treated to retain theshape after removal from the heating form.

One type of mandrel used for winding and forming a vasoocclusive coilaround the surface of the mandrel has a substantially spherical mainbody with six cylindrical posts having a diameter slightly smaller thanthat of the main body, disposed on the body and aligned with the threeorthogonal x, y and z axes through the body of the mandrel, for aligningand shaping one or more portions of the vasoocclusive device as it iswound on the mandrel. One of the posts is longer than the other posts,to serve as a mandrel for helically winding a proximal portion of thevasoocclusive coil. In one variation of the mandrel, the mandrel has amain body that is substantially cubical, with six cylindrical postsdisposed on each of the faces of the main body, and one of the postsbeing longer than the others.

Another type of mandrel has a substantially orthogonal main body withsix cylindrical posts having a diameter slightly smaller than that ofthe main body, disposed on the body and aligned with the threeorthogonal x, y and z axes through the body of the mandrel, for aligningand shaping the distal portion of the vasoocclusive device as it iswound on the mandrel. Preferably one of the posts is longer than theother posts, to serve as a mandrel for helically winding the proximalportion of the vasoocclusive coil. The mandrel may include a threadedaperture in a face of one of the posts and coaxially aligned with theorthogonal axis the post for receiving a corresponding end of agenerally cylindrical handle, which is correspondingly threaded, and thehandle can also be used as a mandrel for winding a portion of thevasoocclusive coil with a helical shape.

Another type of mandrel has a substantially spherical main body, with aplurality of circumferential grooves defined on the surface of the mainbody, and this type of mandrel may additionally have a plurality ofposts mounted on the main body of the mandrel for aligning the occlusivedevice as it is wound on the mandrel. The surface of the mandrel mayalso have one or more apertures for receiving one or more ends of thestrands, to assist winding into the desired form.

Heat treatment of the wound coil at a temperature of about 1100° F. forapproximately four hours or more is typically sufficient to impart theform to the occlusive device when the shape memory material is a nickeltitanium super-elastic alloy. After the heat treatment, the occlusivedevice is removed from the mandrel, and cold worked into the desiredcollapsed elongated configuration for placement into a catheter orcannula for use. When the occlusive device reaches its destination inthe vasculature during vascular therapy, it assumes the primary shapeimparted from the heat treatment on the mandrel.

Such spherical, cubical or orthogonal mandrels for winding ofvasoocclusive coils have proved suitable for winding coils in suchshapes, and allow for the combination of multiple coils or the windingof various shapes in an individual coil, but it would be desirable toprovide a winding mandrel offering a greater variety of options forwinding patterns for forming other shapes of vasoocclusive coils, suchas for forming longer framing coils, and for providing shortertransitions between coils for coils with more than six loops, forexample. The present invention satisfies these and other needs.

SUMMARY OF THE INVENTION

Briefly, and in general terms, the invention provides for a windingmandrel having a pair of generally rounded-cube shaped or orthogonallyflat-sided spherical main bodies connected together, and each having aplurality of cylindrical posts, to provide from ten to twelve availablewinding posts, allowing for a greater variety of options for windingpatterns for forming other shapes of vasoocclusive coils, as well asshort transitions between portions of coils wound on the mandrel.

The present invention accordingly provides for a winding mandrel havinga pair of generally rounded-cube shaped or orthogonally flat-sidedspherical main bodies, each having a plurality of cylindrical postsdisposed on the bodies and aligned with orthogonal x and y axes throughthe bodies of the mandrel, for aligning and shaping one or more portionsof the vasoocclusive device as it is wound on the mandrel. In apresently preferred embodiment, the cylindrical posts are attached toflat sides of the main bodies. In a presently preferred embodiment, theorthogonal x and y axes through the main bodies of the mandrel areoffset with respect to each other. The cylindrical posts typically havea diameter slightly smaller than that of the main bodies. The mainbodies are connected together by a central transition post extendingbetween the main bodies along a longitudinal central z axis through themain bodies. A front end cylindrical post and a back end cylindricalpost are disposed on front and rear ends of the main bodies extendingalong the longitudinal central z axis through the main bodies, providingfor a total of ten winding posts. One of the front end and back endcylindrical posts may be substantially elongated with respect to theother, to provide a handle, or to serve as a post for helically windingan elongated portion of a vasoocclusive coil.

In another embodiment, a short winding post is added between theconnections of the two main bodies for two additional winding posts.

Other features and advantages of the present invention will become moreapparent from the following detailed description of the preferredembodiments in conjunction with the accompanying drawings, whichillustrate, by way of example, the operation of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a rear elevational view of a first embodiment of a windingmandrel according to the present invention.

FIG. 2 is a top plan view of the winding mandrel of FIG. 1.

FIG. 3 is a perspective view of the winding mandrel of FIG. 1.

FIG. 4 is a top plan view of a second embodiment of a winding mandrelaccording to the present invention.

FIG. 5 is a rear elevational view of the winding mandrel of FIG. 4.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring to the drawings, which are provided for purposes ofillustration and by way of example, the present invention provides for awinding mandrel for forming at least a portion of a vasoocclusive coilin a three-dimensional configuration by winding of the coil about one ormore portions of the mandrel.

As is illustrated in FIGS. 1-3, in a first embodiment, the mandrel 10includes ten winding posts 12 (one front post 14, four primary windingposts 16 a, b, c, d, four secondary winding posts 18 a, b, c, d, and oneback post 20) and two generally rounded-cube shaped or orthogonallyflat-sided spherical main bodies 22, 24, with a transition post 26between the two main bodies. Each main body is machined on six sides toprovide flat sides 28 for connecting to the winding posts and the othermain body. The front winding post may be smaller in diameter than thediameter of the other posts, and is typically approximately 75% the sizeof the other posts. This front winding post is connected to one of themachined flat sides and may be generally tangent to the main body 22 asthe starter for the first coil loop.

The four primary winding posts are connected to the other four flatsides perpendicular to the front winding post. These posts form a crosspattern perpendicular to the front winding post.

The second main body 24 is connected at the last machined flat spot ofthe first main body. Four secondary winding posts and a back post areconnected at the machine flat sides of the second main body. The foursecondary winding posts will form a similar pattern as the primarywinding posts, except that they are preferably indexed over or offset(such as approximately 45 degrees, for example), so that the individualsecondary posts line up between the primary winding posts. The backwinding post is mounted on the end opposite to the front winding post,and in line with the front winding post, and is longer to serve as ahandle for holding the mandrel during the winding process, or to serveas a post for helically winding an elongated portion of a vasoocclusivecoil.

In a second embodiment, a twelve post winding mandrel is substantiallythe same as the ten post winding mandrel of FIGS. 1-3, except that ashort winding post is added between the connections of the two generallyrounded-cube shaped or orthogonally flat-sided spherical main bodies fortwo additional winding posts. Referring to FIGS. 4 and 5, in the secondembodiment, the mandrel 30 includes winding posts 32 (one front post 34,four primary winding posts 36 a, b, c, d, four secondary winding posts38 a, b, c, d, and one back post 40) and two generally rounded-cubeshaped or orthogonally flat-sided spherical main bodies 42, 44, with atransition post 46 between the two main bodies. Each main body ismachined on six sides to provide flat sides 48 for connecting to thewinding posts and the other main body. The front winding post may besmaller in diameter than the diameter of the other posts, and istypically approximately 75% the size of the other posts. This frontwinding post is connected to one of the machined flat sides and may begenerally tangent to the main body 42 as the starter for the first coilloop.

The four primary winding posts are connected to the other four flatsides perpendicular to the front winding post. These posts form a crosspattern perpendicular to the front winding post.

The first and second main bodies are connected by the transition post 46between the two main bodies. Four secondary winding posts and a backpost are connected at the machine flat sides of the second main body.The four secondary winding posts form a similar pattern as the primarywinding posts, except that they are preferably indexed over or offset(such as approximately 45 degrees, for example), so that the individualsecondary posts line up between the primary winding posts. The backwinding post is mounted on the end opposite to the front winding post,and in line with the front winding post, and is longer to serve as ahandle for holding the mandrel during the winding process, or to serveas a post for helically winding an elongated portion of a vasoocclusivecoil. Two additional winding posts 50 a, 50 b are mounted to thetransition post 46, extending perpendicularly from the longitudinal axisof the transition post, between the two main bodies, to provide for atwelve post winding mandrel.

It will be apparent from the foregoing that, while particular forms ofthe invention have been illustrated and described, various modificationscan be made without departing from the spirit and scope of theinvention. Accordingly, it is not intended that the invention belimited, except as by the appended claims.

1. A winding mandrel for forming at least a portion of a vasoocclusivecoil, comprising: first and second main bodies, each of said first andsecond main bodies having a plurality of cylindrical posts disposed onthe first and second main bodies, the plurality of cylindrical postsdisposed on the first main body being substantially aligned withorthogonal x and y axes through the first main body, and the pluralityof cylindrical posts disposed on the second main body beingsubstantially aligned with orthogonal x and y axes through the secondmain body; a front end cylindrical post disposed on one of said firstand second main bodies; and a back end cylindrical post disposed on theother of said first and second main bodies.
 2. The winding mandrel ofclaim 1, wherein said first and second main bodies have a plurality offlat sides, and said cylindrical posts are attached to said flat sides,respectively.
 3. The winding mandrel of claim 1, wherein said pluralityof cylindrical posts of said first and second main bodies are angularlyoffset with respect to each other.
 4. The winding mandrel of claim 1,wherein said cylindrical posts have a diameter slightly smaller than adiameter of the main bodies.
 5. The winding mandrel of claim 1, whereinsaid one of the front end and back end cylindrical posts issubstantially elongated with respect to the other.
 6. The windingmandrel of claim 1, further comprising: a central transition postextending between and connecting said first and second main bodies; andat least one central cylindrical winding post connected to and extendingperpendicularly from said central transition post.
 7. A winding mandrelfor forming at least a portion of a vasoocclusive coil, comprising:first and second main bodies, each of said first and second main bodieshaving a plurality of cylindrical posts disposed on the first and secondmain bodies, the plurality of cylindrical posts disposed on the firstmain body being aligned with orthogonal x and y axes through the firstmain body, and the plurality of cylindrical posts disposed on the secondmain body being aligned with orthogonal x and y axes through the secondmain body; a central transition post extending between and connectingsaid first and second main bodies; a front end cylindrical post disposedon one of said first and second main bodies; a back end cylindrical postdisposed on the other of said first and second main bodies; and at leastone central cylindrical winding post connected to and extendingperpendicularly from said central transition post.
 8. The windingmandrel of claim 7, wherein said first and second main bodies have aplurality of flat sides, and said cylindrical posts are attached to saidflat sides, respectively.
 9. The winding mandrel of claim 7, whereinsaid plurality of cylindrical posts of said first and second main bodiesare angularly offset with respect to each other.
 10. The winding mandrelof claim 7, wherein said cylindrical posts have a diameter slightlysmaller than a diameter of the main bodies.
 11. The winding mandrel ofclaim 7, wherein said one of the front end and back end cylindricalposts is substantially elongated with respect to the other.
 12. Thewinding mandrel of claim 7, wherein said at least one centralcylindrical winding post comprises first and second central cylindricalwinding posts connected to and extending perpendicularly from saidcentral transition post.
 13. A method of forming at least a portion of avasoocclusive coil, comprising the steps of: a) providing a windingmandrel including: (i) first and second main bodies, each of said firstand second main bodies having a plurality of cylindrical posts disposedon the first and second main bodies, the plurality of cylindrical postsdisposed on the first main body being aligned with orthogonal x and yaxes through the first main body, and the plurality of cylindrical postsdisposed on the second main body being aligned with orthogonal x and yaxes through the second main body; (ii) a front end cylindrical postdisposed on one of said first and second main bodies; and (iii) a backend cylindrical post disposed on the other of said first and second mainbodies; and b) winding a coil about at least one of said first andsecond main bodies, said plurality of cylindrical posts disposed on saidfirst and second main bodies, said front end cylindrical post, and saidback end cylindrical post to form at least a portion of the coil in athree-dimensional configuration.
 14. The method of claim 13, wherein oneof said front end and back end cylindrical posts is substantiallyelongated with respect to the other, and further comprising the step ofhelically winding an elongated portion of the coil about said one ofsaid front end and back end cylindrical posts.
 15. The method of claim13, wherein said winding mandrel further includes a central transitionpost extending between and connecting said first and second main bodies,and at least one central cylindrical winding post connected to andextending perpendicularly from said central transition post, and whereinsaid step of winding a coil comprises: winding the coil about at leastone of said first and second main bodies, said plurality of cylindricalposts disposed on said first and second main bodies, said centraltransition post extending between and connecting said first and secondmain bodies, said front end cylindrical post, said back end cylindricalpost, and said at least one central cylindrical winding post, to form atleast a portion of the coil in a three-dimensional configuration. 16.The method of claim 15, wherein one of said front end and back endcylindrical posts is substantially elongated with respect to the other,and further comprising the step of helically winding an elongatedportion of the coil about said one of said front end and back endcylindrical posts.
 17. A vasoocclusive coil, wherein at least a portionof said vasoocclusive coil is formed in a three-dimensionalconfiguration according to the method of claim
 13. 18. The vasoocclusivecoil of claim 17, wherein one of said front end and back end cylindricalposts is substantially elongated with respect to the other, and whereinsaid vasoocclusive coil comprises an elongated portion formed byhelically winding the elongated portion of the coil about said one ofsaid front end and back end cylindrical posts.
 19. A vasoocclusive coil,wherein at least a portion of said vasoocclusive coil is formed by: a)providing a winding mandrel including: (i) first and second main bodies,each of said first and second main bodies having a plurality ofcylindrical posts disposed on the first and second main bodies, theplurality of cylindrical posts disposed on the first main body beingaligned with orthogonal x and y axes through the first main body, andthe plurality of cylindrical posts disposed on the second main bodybeing aligned with orthogonal x and y axes through the second main body;(ii) a front end cylindrical post disposed on one of said first andsecond main bodies; and (iii) a back end cylindrical post disposed onthe other of said first and second main bodies; and b) winding thevasoocclusive coil about at least one of said first and second mainbodies, said plurality of cylindrical posts disposed on said first andsecond main bodies, said front end cylindrical post, and said back endcylindrical post to form at least a portion of the vasoocclusive coil ina three-dimensional configuration.
 20. The vasoocclusive coil of claim19, wherein one of said front end and back end cylindrical posts issubstantially elongated with respect to the other, and wherein saidvasoocclusive coil comprises an elongated portion formed by helicallywinding the elongated portion of the coil about said one of said frontend and back end cylindrical posts.